MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 36MM HEADS -3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number 962710000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 09/13/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The revision surgery which was performed on (b)(6) 2013 was caused by tissue response due to mom.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).This product was reported in error since mrn was found to be a duplicate report of mrn 1818910-2013-33043.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

Manufacturer Narrative

Product complaint # (b)(4).Previous follow-up 1 was reported in error.Mrn 1818910-2020-18556 will not be retracted since it has no duplicate report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: 9/10 ULTAMET 36MM HEADS -3
• Type of Device: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10442124
• MDR Text Key: 204008682
• Report Number: 1818910-2020-18556
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: K982918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 962710000
• Device Lot Number: 3085144
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PINNACLE MTL INS NEUT36IDX50OD; SROM 9/10 16X11X130 30; PINNACLE MTL INS NEUT36IDX50OD; SROM 9/10 16X11X130 30
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR